Reported Mar 29, 2017 · Terminated
Mammotome Revolve Dual Vacuum Assist Biopsy System The device is used to sample breast tissue that has been identified…
Devicor Medical Products Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Devicor Medical Products Inc · 300 E Business Way Fl 5 · Cincinnati, OH · 45241-2384
Is this the product you have?
- Mammotome Revolve Dual Vacuum Assist Biopsy System The device is used to sample breast tissue that has been identified as suspicious under imaging guidance
- Lot codes and dates
- F11621304D1
- Amount recalled
- 320
Where it was sold
Why it was recalled
The device did not have Revolve Stereo Probe labeling, no product code indicating the size and length of the probe, no sterilization sticker or lot number.
This product could cause temporary or reversible health problems — stop using it.
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